1. Field of the Invention
The present invention relates to a method and apparatus for therapeutically treating injuries using ultrasound. More particularly, the present invention relates to a method and apparatus which utilizes an ergonomically constructed ultrasonic transducer configured to cooperate with a placement module for placement in proximity to any part of the body for therapeutically treating reflex sympathetic dystrophy.
2. Description of the Related Art
The use of ultrasound. to therapeutically treat and evaluate bone injuries is known. Impinging ultrasonic pulses having appropriate parameters; e.g., frequency, pulse repetition, and amplitude, for suitable periods of time and at a proper external location adjacent to a bone injury has been determined to accelerate the natural healing of, for example, bone breaks and fractures.
U.S. Pat. No. 4, 530,360 to Duarte describes a basic non-invasive therapeutic technique and apparatus for applying ultrasonic pulses from an operative surface placed on the skin at a location adjacent a bone injury. The applicator described in the Duarte patent has a plastic tube which serves as a grip for the operator, an RF plug attached to the plastic tube for connection to an RF source, and internal cabling connected to an ultrasonic transducer. To apply the ultrasound pulses during treatment. an operator must manually hold the applicator in place until the treatment is complete. As a result, the patient is, in effect, immobilized during treatment. The longer the treatment period, the more the patient is inconvenienced. The Duarte patents as well as U.S. Pat. No. 5,520,612 to Winder et al. describe ranges of RF signal for creating the ultrasound, ultrasound power density levels, ranges of duration for each ultrasound pulse, and ranges of ultrasonic pulse frequencies.
U.S. Pat. No. 5,003,965 to Talish et al. relates to an ultrasonic body treatment system having a body-applicator unit connected to a remote control unit by sheathed fiber optic lines. The signal controlling the duration of ultrasonic pulses and the pulse repetition frequency are generated apart from the body-applicator unit. Talish et al. also describes a mounting fixture for attaching the body-applicator unit to a patient so that the operative surface is adjacent the skin location.
While the systems described in these patents relate to therapeutic methods and apparatus for ultrasonic treatment there is a need for ergonomically configured signal generators and transducers which permit patient mobility during the treatment of reflex sympathetic dystrophy (RSD). Further, a need exists for an apparatus which optimizes the treatment of RSD while maintaining patient mobility.
RSD is a disease of the sympathetic nervous system, which is one of the components of the central nervous system. The sympathetic nervous system responds to an injury by activating the pain receptors in the injured part of the body. These pain receptors are activated by signals sent by the sympathetic nervous system through neurotransmitters which transmit neural impulses from one neuron to another. This pain acts as a warning to the injured person that they have been hurt, and that they need to stop whatever they are doing in order to prevent further injury. RSD prolongs this normal sympathetic response to an injury by causing the sympathetic nervous system to continue to stimulate the pain receptors long after the injury has healed. Unless the RSD patient is successfully treated, the pain continues unabated for the rest of his/her life.
Several treatments for RSD include drug therapy; spinal blocks which are administered to the patient by injection into the spine; physical therapy; a transcutaneous electrical nerve stimulator (TENS) that connects to the affected area via electrodes and creates electrical pulses that are supposed to interrupt the pain generation and create serotonin and stimulate the release of endorphins; sympathectomy; and implantable devices, such as a peripheral nerve stimulator.
The ultrasonic treatment apparatus of the present invention may be used for therapeutically treating reflex sympathetic dystrophy (RSD) using ultrasound. The apparatus may include an ergonomically constructed placement module configured for mounting at least one ultrasonic transducer assembly with an integral signal generator which provides excitation signals to ultrasonic transducers within the transducer assembly. Timing control circuitry as well as monitoring circuitry for the proper attachment and operation of the transducer assembly are housed within a portable main operating unit constructed to fit within a pouch worn by the patient. In operation, the placement module is positioned against a part of the patient""s body such that at least one transducer is positioned over pain receptors of the sympathetic nervous system. The placement module is preferably placed against the part of the patient""s body where it has been medically determined includes pain receptors which are continuously being stimulated by the sympathetic nervous system long after the injury has healed. At least one transducer is then excited for a predetermined period of time to impinge ultrasonic waves against the pain receptors. A sensor may also be used for sensing stimulation of the pain receptors before the at least one transducer is excited.
Accordingly, there is provided a kit suitable for ultrasonically treating reflex sympathetic dystrophy while maintaining patient mobility, which comprises:
an ultrasonic transducer assembly having at least one ultrasonic transducer;
a placement module configured to be worn by a patient, said placement module being configured to receive said transducer assembly such that when said placement module is worn, said at least one ultrasonic transducer is positioned in proximity to pain receptors of the sympathetic nervous system;
an ultrasonic signal generator positioned in said ultrasonic transducer assembly;
a main operating unit; and
a sensor coupled to said main operating unit for sensing stimulation of said pain receptors.
Preferably, the main operating unit has an internal power source for powering the signal generator circuitry, a display coupled to the signal generator circuitry to display treatment sequence data, a keypad coupled to the signal generator circuitry to permit user operation and/or entry of data. The signal generator circuitry includes a processor, means for generating a pulsed control signal, and a switch coupled to the processor for regulating the pulsed control signal. A communication interface may be connected between a communication port and the processor to provide a communication link between the ultrasonic signal generator and an external computer or modem. Preferably, the communication interface is a serial communication interface, however, a parallel interface is also contemplated. An alarm is provided to indicate to the user that the treatment time has expired. The alarm is coupled to the processor such that when ultrasonic treatment is completed the processor activates the alarm and terminates ultrasound generation.
The present invention also provides a kit for ultrasonically treating RSD while maintaining patient mobility. The kit includes an ultrasonic transducer assembly, a sensor for sensing the stimulation of the pain receptors, a placement module configured to be worn by a patient and to receive the ultrasonic transducer assembly, an integrated ultrasonic signal generator located in the ultrasonic transducer assembly, a main operating unit (MOU) or controller and a pouch constructed to receive the MOU. Preferably, the MOU has an internal power source and is fitted within a pouch which is releasably secured to a patient during treatment thereby providing patient mobility. A MOU envisioned for use with the present invention is described in U.S. Pat. No. 5,556,372 to Talish et al. which is hereby incorporated by reference.
The MOU is electrically coupled to at least one transducer secured to the placement module and at least one sensor. The signal generator corresponding to each transducer is activated when one or more of the sensors sense the pain receptors being stimulated by the sympathetic nervous system. The activation of a signal generator excites at least one ultrasonic transducer for impinging ultrasonic waves to the pain receptors in the injured part of the body.
A method for ultrasonically treating RSD while maintaining patient mobility is also provided. Once the location of the pain receptors in the injured part of the body is ascertained, for example, by one or more of the sensors, a placement module containing an ultrasonic transducer assembly having at least one transducer and one signal generator is affixed to the injured part of the body such that at least one transducer is in proximity to the pain receptors for the treatment of RSD.
In an alternative embodiment, a series of transducers are attached to a placement module and are controlled by a MOU. In another embodiment, a placement module is provided for securing a plurality of transducers thereto in a plurality of configurations.
Further, the present invention also provides a strip having at least one ultrasonic transducer secured thereto for placement on the patient""s body directly above the pain receptors for the treatment of RSD.